Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.

FDA DeterminedCause 2

OTHER/UNDETERMINED: Pending

Action

Philips issued an Urgent Correction letter dated 09/19/2008 to their consignees, identifying the reason for the recall and the affected products. The firm issued the Field Change Order (FCO) 78100232. Field service engineers will visit each consignee and conduct an inspection of the magnets venting system of Edge, Vista, Eclipse, Polaris, Infinion, and Panorama 0.6T MRI systems. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference "FCO 78100232".